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10th Circuit Majority Says Infuse Off-Label Claims Are Preempted By Congress

DENVER — (Mealey’s) In a 2-1 decision, a panel of the 10th Circuit U.S. Court of Appeals on April 21 affirmed that a plaintiff’s claim alleging off-label promotion and use of Medtronic Inc.’s Infuse bone graft system is preempted by federal law and congressional intent (Patricia Caplinger v. Medtronic, Inc., et al., No. 13-6061, 10th Cir.). 

(Opinion available.  Document #28-150507-003Z.

Patricia Caplinger underwent spinal surgery in which the Infuse device was implanted in an off-label manner:  Instead of being implanted through an anterior procedure, under which the device was approved by the Food and Drug Administration, it was implanted via a posterior procedure.  Caplinger alleged that a Medtronic sales representative recommended the off-label use to her surgeon. 

Caplinger claims to have suffered complications as a result of the off-label use of Infuse. 

The plaintiff sued Medtronic in the U.S. District Court for the Western District of Oklahoma.  The District Court granted Medtronic’s motion to dismiss, finding that the plaintiff’s state law claims were either insufficiently pleaded or preempted by federal law. 

Didn’t ID Parallel Claims

Caplinger appealed to the 10th Circuit. 

The majority said that although medical device claims that parallel federal requirements are not preempted, Caplinger failed to identify a single parallel federal or state regulation to support her design defect and breach of warranty claims.  Although she cited parallel claims for her failure-to-warn, negligence and negligent misrepresentation claims, the majority said they do not provide parallels. 

In fact, the majority said that Caplinger’s state law claims about Medtronic’s advertising and oral and written representations to her and her doctor “substantially exceed the potential scope of any federal regulation she’s identified.” 

The majority said another plaintiff might succeed where Caplinger fails.  But it said she has not identified any “legally viable federal requirement” that might parallel her claims and permit them to go forward. 

360(k)(a) Preempts Off-Label Claims

Section 360(k)(a) of the federal Food, Drug and Cosmetic Act does not distinguish between on- and off-label uses of medical devices, , the majority said.  It said the statute “preempts any effort to use state law to impose a new requirement on a federally approved medical device.” 

Further, the majority said that Congress “spoke directly to off-label uses” in 21 U.S. Code Section 396 when it said doctors may use medical devices in an off-label manner.  “Knowing about (even encouraging) off-label uses in § 396, Congress proceeded in § 360k(a) to preempt any state tort suit challenging the safety of a federally approved device without qualification about the manner of its use.” 

“It’s easy to imagine, too, why Congress adopted a preemption provision that doesn’t distinguish between on- and off-label uses,” the majority continued.  “Any additional state duties on top of those imposed by federal law, even if nominally limited to off-label uses, might check innovation, postpone access to life-saving devices, and impose barriers to entry without sufficient offsetting safety gains.” 

50 State Requirements

“For example, a state’s judgment that a device is unsafe for a particular off-label use could require design changes that adversely affect the device’s safety for on-label uses,” the majority said.  “Requiring manufacturers to comply with fifty states’ warning requirements concerning off-label uses, on top of existing federal on-label warning requirements, might introduce sufficient uncertainty and cost that manufacturers would delay or abandon at least some number of life-saving innovations.” 

“Not everyone may agree with how Congress balanced the competing interests it faced in this sensitive and difficult area,” the majority concluded.  “We can surely imagine a different statute embodying a different judgment.  But strike a balance Congress had to and did, and it is not for this court to revise it by beating a new path around preemption nowhere authorized in the text of the statute and nowhere recognized in any of the Supreme Court’s many forays into this field.” 

The majority opinion was written by Circuit Judge Neil M. Gorsuch.  He was joined by Circuit Judge Harris L. Hartz. 

Partial Dissent

Circuit Judge Carlos F. Lucero concurred in part and dissented in part.  He says Caplinger’s ability to sue Medtronic for introducing misbranded or adulterated devices “is compelled neither by binding precedent nor by the plain text and clear purpose of the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976.” 

Judge Lucero said Caplinger’s claims are not entirely dependent on federal law violations but on state law duties that are not preempted. 

Caplinger is represented by Allison M. Zieve and Scott L. Nelson  of the Public Citizen Litigation Group in Washington, D.C., and James W. Dobbs of Rhodes Dobbs & Stewart in Edmond, Okla. 

Medtronic is represented by Andrew E. Tauber and Daniel L. Ring of Mayer Brown in Washington, Scott M. Noveck, formerly of Mayer Brown in Washington, and Michael K. Brown, James C. Martin and Lisa M. Baird of Reed Smith in Los Angeles. 

Amicus curiae Product Liability Advisory Council Inc. is represented by Alan Untereiner and Donald Burke of Robbins, Russell, Englert, Orseck, Untereiner & Sauber in Washington and Hugh F. Young Jr. of the Product Liability Advisory Council in Reston, Va. 

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